Clearance Summary
OCO DENTAL IMPLANT received FDA 510(k) clearance under submission number K010142, sponsored by O Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-02-01.
- Submission: K010142
- Applicant / Sponsor: O Co., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2001-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.